Time Course and Prognostic Significance of Pulmonary Artery Pressure in Highlanders.

Completed

• Conditions: Sleep Apnea; High Altitude Pulmonary Hypertension

• Registration Number: NCT03165019
• Lead Sponsor: University of Zurich

Brief Summary

The purpose of the current study is to evaluate the clinical and physiologic course of Kyrgyz highlanders with high altitude pulmonary hypertension (HAPH) by performing a longitudinal cohort study. To this end, the investigators will invite the same highlanders who participated in the study in 2012 to undergo follow-up examinations in 2017, in order to allow comparisons of current results with baseline data from 2012.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-22
• Study First Submitted QC: 2017-05-22
• Study Start: 2017-05-24
• Study First Posted: 2017-05-24
• Primary Completion: 2017-08-16
• Study Completion: 2017-08-16
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-15
• Last Update Posted: 2019-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

• high altitude pulmonary hypertension confirmed by clinical presentation and mean pulmonary artery pressure >30 mmHg measured by echocardiography at altitude of residence.
• healthy subjects (high altitude controls)
• Both genders
• Age >16 y
• Kyrgyz ethnicity
• born, raised and currently living at >2500 m
• healthy subjects currently living at <1000 m (low altitude controls)

Exclusion Criteria

• Pulmonary hypertension from other causes, in particular from left ventricular failure as judged clinically and by echocardiography
• Excessive erythrocytosis
• Other coexistent disorders that may interfere with the cardio-respiratory system and sleep
• Regular use of medication that affects control of breathing
• Heavy smoking

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in pulmonary artery pressure	Year 2012 to 2017	Difference in the change in mean pulmonary artery pressure (mPAP measured by echocardiography) 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander

Secondary Outcome Measures

Name	Time	Method
Changes in nocturnal arterial oxygen saturation	Year 2012 to 2017	Difference in the change in the nocturnal arterial oxygen saturation 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander
Progression of oxygen desaturation index	Year 2012 to 2017	Difference in the change in the oxygen desaturation index 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander
Exercise performance	Year 2012 to 2017	Difference in the change in 6 minute walk distance 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander
Progression of cognitive performance	Year 2012 to 2017	Difference in the change in the mean reaction time 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander
Survival	Year 2012 to 2017	Cumulative incidence of death and relocation to lower altitudes between 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander
Progression of quality of life	Year 2012 to 2017	Difference in the change in the mental and physical component score of the SF-36 questionnaire 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander
Arterial blood gas analysis	Year 2012 to 2017	Difference in the change in arterial blood gases 2012 to 2017 in highlanders with high altitude pulmonary hypertension, healthy highlanders and healthy lowlander

Trial Locations

Locations (1)

National Center for Cardiology and Internal Medicine; 🇰🇬 Bishkek, Kyrgyzstan